Why the ISO 14001 revision?

The most widely used Environmental Management System (EMS) standard in the world is the ISO 14001:2004. Over a quarter-million businesses use it worldwide. It was first published in 1996 with a notable update in 2004.

A new and significant revision is underway. It’s expected to be released in summer of 2013 – first draft. Target for final publication is 2015.

Why businesses use ISO standards  A standard is technically a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. In other words, quality. A standard is a practical guide and an ideological benchmark against which to measure systems or products or both. Ideally, ISO standards help assure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors, and increasing productivity. The ISO 14001 EMS standard specifies a process for the control and the continuous improvement of an organization’s environmental performance. The standard encourages a strategic approach to an organization’s environmental policy, plans and actions. A strategic approach is always a good idea.

Why the revision to ISO 14001?  The revision of the ISO standard for Environmental Management Systems (EMS) incorporates a change in document structure. That’s pretty much it. Specifically, there are changes in clause hierarchy, including the nesting area of many subclauses. The adjustments reflect a new universal structure — a standard if you will — recently approved for implementation across all next-generation ISO standards. Best way to approach this new ISO 14001 document is to absorb the new structure. Be mindful that any current processes or products that are ISO 14001:2004 compatible will remain acceptable under ISO 14001:2015. There is no need to rush out and start making changes. However, keep an eye on shuffled clauses in the documentation, as with the following:

Requirements for an EMS will be organized into Clauses 1 – 10:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

From the intelligence we’ve gathered, there is nothing Quality Professionals need to do differently to remain in compliance with the standard revision. But it might be time to familiarize ourselves with the new structure, and if not today, then bookmark this page for reference later on.

New TSCA Reform Bill from Lautenberg

U.S. chemical law reform has the best chance to pass as we’ve seen since 1976.

Senator Lautenberg has not been in great health these past few months. His detractors in the US Senate, in powerful lobbies— and just in principle— seem to be softening a bit. We are witnessing the final months of the final term of one of the most legendary public servants in United States history. Whether you love him or prefer to dine at a different table, such a long and passionate career will certainly garner at least some of the respect it deserves. Not that Lautenberg is looking for respect. He’s looking for legacy: he wants to see chemical legislation reform happen in America, no matter what.

In what could be a final bid to make it happen, the Senator has introduced a new version of a bill that would update the Toxic Substances and Chemicals Act (TSCA). It is identical to the legislation that was sponsored by 30 Senators and reported favorably out of the Environment and Public Works Committee in the 112th Congress. Compared to earlier versions of the legislation, it includes a number of significant changes that reflected input from a broad range of stakeholders including federal agencies, state governments, the chemical industry, and public health advocates.

An update is something that almost everyone agrees must happen, from tree-huggers to the ACC to 77% of the US population. The disagreement, as ever, is in the specifics of the bill. TSCA reform is always held up on minutiae and absolutely nothing ever happens. However, with sentiment rising in favor of the august public servant, now is as likely a time as we’ve seen in the past 12 years to consider TSCA reform a real legislative possibility.

Under TSCA, EPA’s ability to protect human health and the environment from harmful chemicals is severely limited. These legal restrictions are so burdensome that, of the more than 84,000 chemicals on the inventory, EPA has been able to require health and safety testing of about 200, and banned only five, since TSCA was enacted in 1976.

Americans and even industry overwhelmingly support legislation to reform TSCA. Recent polling shows strong bipartisan support across the country, as well as strong support from small business owners.

— 77% of Americans support TSCA reform, says a recent poll by Republican firm Public Opinion Strategies
— 75% of small business owners support stronger regulations on toxic chemicals

The Safe Chemicals Act of 2013 addresses each of the core failings of TSCA. To read the specifics of the issues it addresses, please refer to the summary or to the actual bill as proposed.

GHS Timeline in USA

The Globally Harmonized System (GHS) of Classification and Labeling of Chemicals is a worldwide initiative to promote standard criteria for classifying chemicals according to their health, physical and environmental hazards.

OSHA-GHS-timeline-date-USA

GHS is a universal pictograph language. So that a worker in Asia, or in the Americas —or in Africa or Europe or Antarctica — can all read and render the same hazard insignias at a glance. GHS makes sense.

A lot changes with the new system. Most readers of this blog are familiar with the new system’s use of pictograms, hazard statements, and signal words “Danger” and “Warning” to communicate hazard information on product labels and safety data sheets.

So what are the GHS deadlines for US companies?  At the right you’ll see a graphical timeline showing dates for US implementation of GHS.

For help with GHS compliance, contact your favorite consultancy or check with a neutral, platform-agnostic software provider. On the software note, the GHS challenge is formidable enough to have spawned newbie GHS solutions. Do basic Google searches and research. Talk to a few software vendors. Actio Corporation is a good example of a veteran, proven software company that can help with GHS conversion. Whether you decide to use software or not is up to you. Just know that a software company might really help with your GHS challenge.

GHS: A Refresher

As the first major US deadline for the Globally Harmonized System of Classification and Labelling approaches, people are starting to ask the basic questions all over again. And fair enough. Top question?

“Remind me, what’s the difference between OSHA’s previous HazCom standard and the new one (for GHS)?

The new HazCom Standard is written as a modification to the existing standard. The parts of the standard that do not relate to the GHS, or that are already consistent with it, are unchanged. Accordingly, some terms have also been updated. We are no longer going to “assess” so much as we are going to “classify” (see image below). And “material safety data sheet” has been changed to the simpler, “safety data sheet.”

changes-in-HCS-2013

Changes in purpose of the HCS, this is also interesting:

OSHA-HCS-updates

For more, see a comparison of the entire document online, line by line. But this primer should remind you. And key deadlines for the new GHS?  Coming soon in a separate blog post. For 2013 what we need to pay attention to is this one:

2013-HazCom-deadlines

And what does “training” mean, exactly?

The GHS states in Chapter 1.4, Section1.4.9, the importance of training all target audiences to recognize and interpret label and/or SDS information — and to take appropriate action in response to chemical hazards. Training requirements should be “appropriate for and commensurate with the nature of the work or exposure.”

Key target audiences include workers, emergency responders and also those responsible for developing labels and SDSs. To varying degrees, the training needs of additional target audiences have to be addressed. These should include training for persons involved in transport and strategies required for educating consumers in interpreting label information on products that they use.

Here is a helpful brochure summarizing what your employees need to know/be competent in by November 30, 2013: http://www.osha.gov/Publications/OSHA3642.pdf

If you’re curious about technology that can help you comply, consider the award-winning SDS Vault program. (Award information is rolled into a dynamic case study with the manufacturer of Behr paints.)

Going for Gold — and 3T’s

Background information, compliance assistance and other resources on Conflict Minerals can be found here: Actio Conflict Mineral Public Library.

gold-and-the-SEC

Conflict minerals are widely used in many industrial sectors such as electronics and communications, aerospace, automotive, jewelry, healthcare devices, and persified industrial manufacturing. That touches a lot of our supply chains.

So for those wondering about the status of the lawsuit against the SEC regarding the Conflict Minerals rule under the August 1012 Dodd-Frank law, below is a plain-English summary of the charges against the SEC. The SEC is expected to respond tomorrow, March 1, so it’s important to know what charges the SEC will be answering. Please read on.

In discussing a lawsuit against the SEC regarding the Conflict Minerals law, corporate attorney Dynda A. Thomas of Squire Sanders has this to say:

There can hardly be any disagreement with the stated goal of the SEC’s Conflict Minerals Rule. Congress directed the SEC to enact rules requiring disclosure about the use of conflict minerals because it believed that the exploitation and trade of conflict minerals from the DRC were helping to finance armed conflict there — conflict characterized by extraordinary levels of violence, including sexual- and gender-based violence. …

What’s wrong with the SEC conflict minerals rule

It’s worth mentioning that one unintended consequence of the SEC rule is that companies engage in “unofficial embargo” of materials from the area. Not wanting to expose themselves to conflict mineral risk, companies simply look for their raw materials elsewhere.  According three Katten lawyers from the the ACC affiliated Lexicology group, the petitioners argue that the court should “strike down” the conflict minerals rule. These are the core reasons behind the lawsuit:

  1. the SEC failed to conduct a proper cost-benefit analysis — not only did not determine if the Congo and surrounding areas would measurably benefit from the rule but also did not determine whether costs to issuers were reasonable. While it’s not mandatory that legislation like this rule do a cost/benefit analysis in order to become law, according to its own internal rules, the SEC does have to study the costs and benefits; whether this was done sufficiently is unclear
  2. the SEC mistakenly interpreted the statute to apply to companies that do not manufacture any products; companies that “contract for the manufacture of products” should be considered separately
  3. the rule seems to create an impossible loop: it allows smaller issuers four years to create the infrastructure necessary to trace conflict minerals in their supply chain, while giving larger issuers only two years, despite acknowledging that many large issuers cannot meet their obligations under the rule without obtaining information from smaller companies
  4. the rule requires a violation of the First Amendment in its material disclosure requirements:  requiring companies to describe their products as “not DRC conflict free,” even in circumstances in which a company is simply unable to trace their supply chains to determine their minerals’ origins, thereby possibly forcing companies to associate themselves falsely with groups engaged in human rights violations
  5. the rule wrongly (and vaguely) requires due diligence and a Conflict Minerals Report from companies that merely have a “reason to believe” their minerals “may have originated” in the covered region (rather than limiting the rule’s application to companies whose minerals “did originate” in the region)

REACH Review Published

So, after 5 years of REACH regulation, what is the public perception of chemicals in Europe?

The European Commission ran a “Eurobarometer” survey on the public perception of chemicals. The target sample size in most countries was 1,000 interviews. In total, 25,557 interviews were conducted.

According to the survey, citizens are generally well aware of the wide application of chemicals. 61% of Europeans say that chemicals on the EU market today are safer than 10 years ago. Furthermore, 69% of Europeans consider chemicals unavoidable for their daily life and 75% relate them to industrial innovations.

More than half of the respondents agree that chemicals can help reduce the use of natural resources. Nevertheless, only 43% of respondents agree that chemicals can contribute to a better environment. In general, Europeans are split on who’s ensuring the safety of chemical substances, thinking it’s either industry who’s responsible or public authorities. Come to think of it, it’s fair to say many insiders are confused about that too!

Chemicals in Europe are safer under REACH. All this because on Feb. 5, ECHA released the published version of the 5-Year REACH Review.

ECHA is saying that the use of chemicals in Europe has become considerably safer since the REACH regulation entered into force. More readily available information about chemical substances on the market and better targeted risk management measures mean that risks from substances registered under REACH have significantly decreased. This trend is expected to continue as industry continues to work towards finding substitutes for the most hazardous chemicals.

Five years after REACH’s entry into force, companies have now registered 30,601 files with the European Chemicals Agency (ECHA), describing the uses and properties of 7,884 chemical substances manufactured or placed on the market.

Public opinion is still warm towards REACH and its effects, according to that Eurobarometer survey published today, mentioned above.

The REACH 5-Year Review upshot. The review concludes that while some adjustments are needed, no major overhaul is required. The main points to consider are as follows:

  1. The report makes recommendations to improve REACH implementation. These include improving the quality of registration dossiers, enhancing intelligent safety data sheet management as a central risk mitigation tool, and addressing issues related to cost sharing within Substance Information Exchange Forums (SIEFs).
  2. The report calls strongly on industry to improve the quality of dossiers submitted. Based on evidence gathered by ECHA relating to the identification of substances and determination of “sameness,” the Commission services will consider options to improve the situation, including legal measures.
  3. The Commission rules out any dramatic changes to the regulation of nanomaterials in the EU in 2013.
  4. There is insufficient information to decide now if certain types of polymers should be registered so no action is expected in 2013.
  5. There are no major overlaps with other EU legislation.
  6. Considerable  efforts to develop alternative methods to animal testing have been made and will continue:  since 2007, the Commission has made available € 330 million to fund research in this area.
  7. Enforcement could be improved. As this is the responsibility of the Member States, the report recommends that Member States reinforce coordination amongst them. See previous blog post on REACH penalties.
  8. Although the report identifies a need for some adjustments to the legislation, the EC wants to ensure legislative stability and predictability for European businesses. No changes to REACH’s main terms are proposed at present.
  9. The report recommends reducing the financial and administrative burden on SMEs in order to ensure the proportionality of legislation and to assist them to fulfil all their REACH obligations.
  10. To promote the competitiveness of the European chemical industry, the Commission will soon propose to reduce registration fees for SMEs.

Next steps. There are a few itemized next steps already moving forward:

  1. The Commission will discuss the outcomes of the REACH review with the Member States and stakeholders.
  2. In cooperation with Member States and ECHA, the Commission is developing a roadmap to assess and identify substances of very high concern (SVHC). It will set out clear milestones, deliverables and the pision of work between the Commission, Member States and ECHA to place all relevant SVHC on the candidate list by 2020.
  3. The Commission will also look into greater fee reductions to SMEs to spread the financial impact of registration more evenly.
  4. The next deadline under the REACH regulation is 31 May 2013, by when industry must register all phase-in substances manufactured or imported in the EU at or above 100 tonnes a year.

Background. REACH is the Regulation on Registration, Evaluation, Authorisation and restriction of CHemicals. The REACH review examines the overall operation of REACH and the attainment of its unique set of objectives – a high level of protection of human health and the environment, the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.

From 1999 to 2009 the EU chemical industry grew slightly higher than the average rate for all manufacturing sectors, and has largely recovered from the crisis of 2008. The industry generates a positive trade balance and is particularly well-performing in high margin sectors of specialty chemicals. In 2003, when REACH was proposed, the EU was the world’s largest chemicals market with approximately 30 % of global chemicals sales. Today it amounts to about 21 %, with China now being the largest chemicals market. However the EU remains the world’s largest exporter of chemicals and over recent years the industry’s turnover has increased in absolute terms.

Review is here: http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review2012/index_en.htm

California’s BPA Threshold

BPA has officially been assigned a maximum daily threshold limit by the California Office of Environmental Health Hazard Assessment (OEHHA). In policy and compliance terms, this means OEHHA has officially announced a proposal to adopt a Proposition 65 Maximum Allowable Dose Level (MADL).

The MADL for exposures to bisphenol A (BPA) is set at 290 micrograms per day.

The notorious B.P.A. BPA is being considered for Prop 65 listing due its being “known to cause reproductive toxicity.” (In the event that BPA does not wind up listed, OEHHA will not proceed with the adoption of this Maximum Allowable Dose Level (MADL)).

OEHHA says it is proposing the MADL of 290 micrograms per day at this time to assist the public in assessing the potential impact of the listing.

Here’s some context. In a 2011 study reported by Fox News, people who ate one serving of canned soup every day for five days had BPA levels of 20.8 micrograms per liter of urine. Compare this to the control group, who ate fresh soup for those five days and had just 1.1 micrograms per liter.

The difference in BPA levels represents a 1,221 % increase in humans— from just one serving of canned soup per day. There are other canned consumable goods people eat every day. BPA shows up in food from restaurants, in prepared and frozen foods, and in places you might not expect, like some paints, packaging and of course, plastic bottles. A person’s daily total exposure is the thing of concern here.

BPA and worker safety. The levels of BPA seen in the study participants were “among the most extreme reported in a nonoccupational setting,” the researchers wrote in their report.

This is a reminder that while consumers should watch their BPA exposures, folks in occupational settings should really watch theirs.

Packagers, technical supervisors, laboratory technicians and maintenance workers in BPA manufacturing facilities and facilities using BPA to manufacture, say, epoxy resin are examples of occupational environments where male workers in one Kaiser study showed four times as many endocrine-disruption related conditions. Male hormonal disruptions result in conditions such as, well, you know. And if you don’t know, read the study.

However, California Proposition 65 exists primarily to protect citizens of California, not so much as a worker safety measure. So news surrounding this BPA moment will focus on can linings and cash register receipts and other such areas where average citizens are exposed.

Feedback from industry. In legalese, setting a maximum threshold for exposure to BPA would happen via amendment of Section 25805(b) of Title 27 of the California Code of Regulations.

Any written comments concerning this proposed action, regardless of the form or method of transmission, must be received by OEHHA by 5:00 p.m. on March 11, 2013. All comments will be posted on the OEHHA website at the close of the public comment period, so don’t say anything your company won’t stand behind later.

Feedback from the public. Just because it’s usually industry who comments on these matters doesn’t mean the public shouldn’t (or, necessarily, should). Comment periods are open. If you have some knowledge of BPA and related issues and you have an opinion on the proposed threshold, you should email comments to: P65Public.Comments@oehha.ca.gov — they’ve asked that folks please include “BPA MADL” in the subject line.

The most recent Cal Prop 65 list can be found here: http://oehha.ca.gov/prop65/prop65_list/files/P65single010413.pdf

Predictions for 2013

For this column, we compiled the top 5 predictions for compliance in 2013 as it will concern members of the Actio Network (and the majority of business persons with industrial concerns). Categories encompass the electronics industry, EPA/TSCA/etc, Power, Air and Water regulations — and tech tools to manage it.

1. Electronics. This is a highly readable and insightful “quick takes” from the editor of Circuits Assembly magazine, Mike Buetow. His six bullet point predictons for 2013 hit the mark, including:

  1. Accelerated migration of manufacturing in North America
  2. Flextronics will purchase significant stakes in RIM (Research In Motion)
  3. Action in the PCB CAD bullpen

Buetow’s six predictions

2. EPA, TSCA, REACH. Bergeson & Campbell published a comprehensive piece, predicting 2013 for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). An excellent document. Predictions include:

  1. TSCA legislation outlook: dim, with updates unlikely
  2. OPPT will continue leveraging existing TSCA authorities to assess and regulate chemicals
  3. REACH: deadlines as usual

Other topics in the article: Regulation of nanoscale materials, California Safer Consumer Products Regulations, FIFRA/FQPA, rodenticide cancellation, pollinators, Endocrine Disruptor Screening Program (EDSP), Asia forecast: China, Chinese Taipei (Taiwan), Japan, Korea.

Get the EPA / TSCA outlook

3. Software. In the 2013 quality and stewardship arena, expect to see huge strides in technology. Next-generation software engines will solve (examples provided, use links):

  1. Material disclosure and supplier management
  2. GHS document authoring and management
  3. SEC conflict mineral reporting

4. Power companies. This piece includes the top ten predictions for the power industry by the editor of Power magazine. Predictions include:

  1. Kyoto 2 is Dead
  2. Natural Gas Prices Rise 20%
  3. The Carbon Tax Dies

See the top ten

5. EPA: air and water. Over the next two years, EPA will propose and finalize many new and significant rules, particularly under the Clean Air and Clean Water Acts. The pipeline is full, and electric utilities, agricultural operations, the construction and real estate industries, and facilities using large boilers need to pay special attention. Specifically there will be:

Stricter Air Requirements Utility MACT/Mercury Rule, Boiler MACT, and Revised PM2.5 National Ambient Air Quality Standard (NAAQS) for starters.

Stricter Water Requirements  Revisions to the Concentrated Animal Feeding Operations Discharge Permitting Regulations — Particularly, areas like the Chesapeake Bay are implied, where nutrients are believed to be significant contributors to water quality impairment, will see more stringent permitting requirements.

Effluent Guidelines for The Construction and Development Industry  New construction activities can expect more stringent requirements governing stormwater discharges.

Stormwater Discharges from Developed Sites  Expect to see a proposed rule on restrictions on stormwater flow (as opposed to limits on pollutants in stormwater) possibly as early as the summer of 2013.

Effluent Guidelines for Electricity Generating Units  EPA expects rulemaking to address discharges from ash ponds and flue gas desulfurization (FGD) air pollution controls, as well as other power plant waste streams, for power plants. The proposal should be released in the next few months.

Definition of “Waters of the United States”  EPA and the U.S. Army Corps of Engineers are attempting to develop a proposed rule to clarify which waters are subject to regulation and protected by the Clean Water Act. It is not clear when or if this proposed rule will be published.

by Thomas G. Echikson

Details here

—-

For reference, a list of EPA forecasted projects

For reference, try browsing the list below to get a predictive view of forecasted projects for 2013.  The information in EPA’s forecast database (link below) is based on the best information available at the time of posting and is intended for prospective contracting planning purposes. Please note that some records in the database contain the statement of work (SOW) from the current contract, which can be interesting.

2013 EPA Project Forecast Database

REACH: 54 New Substances!

Some 54 new substances have been added to the Candidate List under Europe’s REACH regulation. Download the complete list (136 substances) for your records and reference.  (No registration required to download a copy.)

The legal obligations that companies may have resulting from the inclusion of substances in the Candidate List apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles containing any of the 54 substances included in the Candidate List by December 19, 2012 have six months from December 19 to notify ECHA if both of the following conditions apply: (i) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and (ii) the substance is present in those articles above a concentration of 0.1% weight by weight.

REACH-SVHC-LIST-DOWNLOAD

Download available here.

There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. Information on the notification of substances in articles and related submission tools, as well as a manual with instructions on how to create and submit a notification dossier are available on ECHA´s website. A webform to facilitate the submission of substances in articles notifications is also available. Nevertheless, datasets are also provided for submission of the notifications via REACH-IT. “Silver bullet” technology for REACH and similar material disclosure compliance challenges in a supply chain is also available.

The Candidate List now contains 138 substances.

China Chemical Registration

As of March 1, 2013, the following must obtain an appropriate Registration Certificate for Environmental Management Registration for Hazardous Chemicals in China:

  • newly established companies that produce hazardous chemicals
  • companies using hazardous chemicals for production purposes
  • companies importing or exporting hazardous chemical.

Registration Certificates will be issued by China’s Environmental Protection divisions and will be valid for three years. Existing companies that produce or use hazardous chemicals for production purposes have a three-year transition period to complete registration— this registration is separate from the registration required by the State Administration of Work Safety and it is said to aim at better tracking of the environmental impact caused by hazardous chemicals, rather than the health and safety impact.

Perhaps the biggest concern with the new Chinese chemical policies overall is how they add to the larger international weave of chemical restrictions, standards and regulations. The way to handle China’s hazcom rules— all of them, new and future— is to make sure that the way your company handles REACH, RoHS, Prop 65, GHS and TSCA also handles any Asian restrictions as well, from South Korea to Japan to India and China.

Newbies, look out. Newly established manufacturers must register their hazardous chemicals before completion and final acceptance of their project, while importers must register before they import a hazardous chemical for the first time. And the Registration must be complete before the final acceptance of any new construction projects or expansion projects of hazardous chemical manufacturers and users.

Legacy. Entities in China that manufacture or import hazardous chemicals must register their hazardous chemicals with China’s State Administration of Work Safety and China’s Ministry of Environmental Protection (MEP), while entities that use hazardous chemicals must register with China’s Ministry of Environmental Protection (MEP). Hazardous chemical manufacturers and users must also engage in material disclosure, that is, public disclosure of information regarding their hazardous chemicals production and use.

Information to submit when registering includes:

  1. classification and labeling information
  2. physical and chemical properties
  3. primary use
  4. hazardous characteristics
  5. safety information for storage, use and shipment
  6. emergency response measures.

In addition, hazardous chemical manufacturers must maintain a 24-hour domestic telephone hotline to provide users with emergency consulting services and technical instructions and other assistance with respect to hazardous chemical accidents. Another option is to assign the hotline to the Chinese government.

Action. In light of these regulations, the legal firm Baker & McKenzie suggests that entities in China who are manufacturing, importing, or using hazardous chemicals should consider: Designating certain employees, or creating a specific department, to be in charge of hazardous chemical registration and ongoing compliance requirements Conduct due diligence on suppliers in China who may be subject to these requirements as part of

Supply Chain Management (SCM). Rather than setting up an entire department to manage these changing compliance requirements in Asia, we would suggest subscribing to a secure SaaS software that manages compliance for you. In the end, it’s the most cost-effective way to manage fluctuating global regulations and supplier relations around them.